PULMOPRODIFF 0.25%/18% MEDICINAL GAS

Introduction

Package Leaflet: Information for the User

PulmoProDiff 0.25%/ 18% compressed medical gas

carbon monoxide (CO)/helium (He)

Read this package leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or nurse.

• If you experience side effects, consult your doctor, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What PulmoProDiff is and what it is used for
2. What you need to know before starting to use PulmoProDiff
3. How to use PulmoProDiff
4. Possible side effects
5. Storage of PulmoProDiff
6. Contents of the pack and further information

1. What PulmoProDiff is and what it is used for

PulmoProDiff is a medical gas for exclusive use in the diagnosis of lung function. It is used during diagnostic tests of lung function: determination of diffusion capacity/transfer factor and lung volume.

The medical gas PulmoProDiff can only be used in patients who are able to perform the test, regardless of their age.

2. What you need to know before starting to use PulmoProDiff

Do not use this medical gas:

Unless your doctor has asked you to undergo respiratory function tests.

Warnings and precautions

Consult your doctor before starting to use PulmoProDiff.

If you have a history of coronary artery disease, you may be at risk of myocardial ischemia caused by carbon monoxide, as indicated by changes in the ECG (ST segment descent).

Children

This medical gas should be used with caution in children due to the lack of data on the systemic toxicity of this mixture.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medical gas.

Driving and using machines

The use of this medical gas during respiratory function tests does not affect the ability to drive and use machines.

3. How to use PulmoProDiff

PulmoProDiff can only be used for respiratory function tests by inhalation and exactly as your doctor or the responsible medical staff has indicated. If you have any doubts, consult your doctor or the medical staff attending you.

Only the doctor or the responsible medical staff should decide the duration of the respiratory function test and the frequency of repetition of the test.

Safety instructions

Smoking or lighting open flames is not allowed in the room where the medical gas is being used.

If you have any doubts about the use of this medicine, consult your doctor or the medical staff attending you.

4. Possible side effects

During inhalation of this medical gas during respiratory function tests, very unlikely side effects such as dizziness, chest pain, and disorientation may occur. If any symptoms of this nature occur during the use of the medical gas, inhalation should be stopped immediately and medical treatment should be administered.

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of PulmoProDiff

Keep this medical gas out of the sight and reach of children.

Do not use this medical gas after the expiration date shown on the gas cylinder after CAD.

Do not dispose of the container of this medical gas; return it to the supplier.

These measures will help protect the environment.

Store below 50 °C.

All regulations regarding the handling of pressure vessels must be followed.

Store in the original gas cylinder. Do not transfer the contents of the original gas cylinder to another gas cylinder.

Store gas cylinders indoors, in well-ventilated rooms or outdoors under cover and protected from adverse weather conditions.

Protect gas cylinders from impacts, falls, oxidizing and flammable materials, humidity, heat sources, or ignition.

Different types of medical gas should be separated from each other. Full and empty gas cylinders should be stored separately.

6. Contents of the pack and further information

Composition of PulmoProDiff

• The active ingredients are carbon monoxide and helium.
• The other components are nitrogen and oxygen.

Appearance of the product and contents of the pack

PulmoProDiff is a colorless, odorless, and tasteless compressed medical gas.

10-liter aluminum gas cylinder (identified with a bright green tip and white body) filled to a pressure of 150 bar, equipped with a residual pressure valve made of copper with a specific outlet connection.

Marketing authorization holder and manufacturer

Marketing authorization holder

Messer Ibérica de Gases S.A.U.

Autovía Tarragona-Salou, km. 3.8

E-43480, Vilaseca (Tarragona)

Spain

Manufacturer

Messer Austria GmbH

Industriestraße 5

2352 Gumpoldskirchen

Austria

This medicine is authorized in the EEA member states under the following names:

PulmoProDiff Netherlands, Austria, Germany, Poland, Romania, and Spain

Zyplorin: Czech Republic

Date of the last revision of this package leaflet:

May 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/